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Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01367132
First Posted: June 6, 2011
Last Update Posted: February 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medstar Health Research Institute
  Purpose

The primary objective of this study is to determine the detection rate of two- or three-vessel umbilical cord at the time of nuchal translucency screening between 11 and 13 6/7 weeks gestation.

Hypothesis: Detection rate of the number of vessels during first trimester will be as accurate as the detection of vessels during the second trimester.


Condition Intervention
Umbilical Cord Procedure: Doppler ultrasound

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Number of Umbilical Cord Vessels at the Time of Nuchal Translucency Screening

Resource links provided by NLM:


Further study details as provided by Medstar Health Research Institute:

Primary Outcome Measures:
  • Detection of the number of vessels in the umbilical cord between 11 and 13 6/7 weeks. [ Time Frame: 11-13+6 weeks ]
  • Detection of the number of vessels in the umbilical cord between 18 and 23 6/7 weeks. [ Time Frame: 18 - 23 6/7 weeks ]

Secondary Outcome Measures:
  • Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord between 11 and 13 6/7 weeks. [ Time Frame: 11-13+6 weeks gestational age ]
  • Sensitivity and specificity of transabdominal sonography at detecting vasculature of the cord during the second trimester. [ Time Frame: 18-24 weeks gestation ]

Enrollment: 123
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Doppler ultrasound
    Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing nuchal transluscency screening during 11-13+6 weeks gestation, followed by anatomy scan at 18-24 weeks gestation.
Criteria

Inclusion Criteria:

  • Singleton or multiple-gestation pregnancies in patients presenting for NT screening between 11 and 13 6/7 weeks gestation and CRL between 45-84mm as determined at the time of the ultrasound
  • Age 18 and older

Exclusion Criteria:

  • Patients who are incapable of informed consent or minors
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01367132


Locations
United States, District of Columbia
Georgetown University Hospital, MedStar Health
Washington, District of Columbia, United States, 20007
Washington Hospital Center, MedStar Health
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Medstar Health Research Institute
Investigators
Principal Investigator: Rita W Driggers, MD Washington Hospital Center, MedStar Health
  More Information

Publications:

Responsible Party: Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT01367132     History of Changes
Other Study ID Numbers: MedStar 2010-450
First Submitted: June 1, 2011
First Posted: June 6, 2011
Last Update Posted: February 22, 2013
Last Verified: February 2013

Keywords provided by Medstar Health Research Institute:
ultrasound
first trimester
umbilical cord

Additional relevant MeSH terms:
Glucuronyl glucosamine glycan sulfate
Anticoagulants
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Hypoglycemic Agents
Physiological Effects of Drugs